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TrialNCT07489274

Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).

Status
RECRUITING
Phase
PHASE4
Last update posted
09/04/2026
Start
04/04/2026
Sponsor
Ole Hyldegaard
Specialties
emergency, cross-cutting

Conditions: Necrotizing Soft Tissue Infection

Brief summary

Necrotizing soft-tissue infection (NSTI) is a rare, severe, fast-progressing bacterial infection within the soft tissue compartment. The NSTI mortality rate remain high and largely unaltered in the last decades. The standard of care in NSTI is multidisciplinary and includes surgery, intensive care, and broad-spectrum antibiotics. Hyperbaric oxygen (HBO2) treatment is an adjunctive treatment potentially improving survival, but is not standard of care in many centres, presumably as no evidence of its benefit from randomized clinical trial exists. The primary objective of this trial, HOT-NSTI, is to investigate the effect of adjunctive HBO2 treatment on 30-day all-cause mortality in patients with NSTI.

Protocol documents and results are not hosted here. Verify every detail on ClinicalTrials.gov.

Clinical Evidence